Introduction

Victims of sexual assault should be treated in an emergency department or equivalent healthcare setting where all appropriate medical resources are available as needed. (A3)

Although infrequent, cases of HIV transmission following sexual assault have been described [Murphy et al. 1989; Myles et al. 2000]. This guideline addresses the unique considerations involved in evaluation, counseling, and support for HIV exposures resulting from sexual assault.

Assessment

Assessment

When deciding whether to recommend the initiation of PEP following sexual assault, the clinician should assess and carefully weigh the following factors: (A3)

Whether or not a significant exposure has occurred during the assault

Knowledge of the HIV status of the alleged assailant

Whether the victim is ready and willing to complete the PEP regimen

The clinician’s decision to recommend PEP should not be influenced by the geographic location of the assault. (A2)

Degree of Risk Based on Type of Exposure

Clinicians should recommend HIV PEP to victims when significant exposure may have occurred, as defined by direct contact of the vagina, penis, anus, or mouth with the semen, vaginal fluids, or blood of the alleged assailant, with or without physical injury, tissue damage, or presence of blood at the site of the assault. (A2)

PEP should also be offered in cases when broken skin or mucous membranes of the victim have been in contact with blood, semen, or vaginal fluids from the alleged assailant. Similarly, PEP should be offered in cases of bites that result in visible blood. (A2)

Considering the HIV Status of the Alleged Assailant

Unless the identity and HIV status of the alleged assailant have been clearly established to assist with the decision-making, PEP should be promptly initiated and should not be delayed while awaiting test results from the alleged assailant. (A2)

Even when the alleged assailant is known to be HIV-infected, the decision to recommend PEP should be based on the nature of the exposure and the victim’s ability to complete the regimen. (A3)

If PEP has been initiated and HIV screening tests from the alleged assailant are found to be negative, including rapid test and 3rd- or 4th-generation EIA or HIV RNA assay,* then PEP should be discontinued. Decisions to discontinue PEP should be made in consultation with a clinician experienced in HIV PEP. (B3)

*Testing protocols for alleged assailants are dependent on whether the test results will affect the victim’s completion of PEP (seeDefendant Testing Guidance).

Although the seroprevalence of HIV in different New York communities may vary, the HIV status of an individual who has been accused of perpetrating a sexual assault remains unknown until that individual has been tested. It is also important to consider that HIV prevalence in sexual assailants may be higher than that in the general population [Rich et al. 2002]. In the acute setting of sexual assault, the decision to recommend prophylaxis should not be based on the geographic location of the assault but rather on the nature of the exposure during the assault, the readiness of the victim to initiate and adhere to the prophylactic regimen, and the HIV status of the alleged assailant, if known.

Degree of Risk Based on Type of Exposure

Studies of sexual assault show a large range for the incidence of anogenital trauma following assault (20%-85%) [Grossin et al. 2003; Riggs et al. 2000; Sugar et al. 2004; Jones et al. 2003]. The absence of visible trauma does not indicate that an assault did not occur; microabrasions and bruising are common and the appearance of these manifestations following sexual assault may be delayed. Oral trauma may also occur during sexual assault with potential exposure to blood, semen, or vaginal fluids from the alleged assailant, which would carry a potential risk for HIV exposure. Bites or trauma may be inflicted during an assault and are indications for prophylaxis if there is the possibility of contact with blood, semen, or vaginal fluids from the alleged assailant.

In most instances, the HIV status of the alleged assailant will not be known and cannot be available in sufficient time to influence the decision to initiate PEP. If the HIV status of the alleged assailant is established and confirmed, that knowledge should be used in decisions to initiate or continue PEP, as well as to assist in choosing the PEP regimen if viral resistance data are available.

When the victim knows the alleged assailant personally, assumptions about HIV status or risk should have limited influence on the decision to initiate prophylaxis. Familiarity with the alleged assailant may influence the victim’s perception of risk, which will influence his/her decision to accept PEP. Because HIV risk behaviors and status may be hidden from close friends and family, decisions based on familiarity with the alleged assailant should be made cautiously. It is not possible to know whether an alleged assailant has HIV infection solely on the basis of risk behaviors. Categorical judgments should not be made on the basis of perceived risk. The decision to offer prophylaxis should be based on whether significant exposure has occurred during the assault rather than on the risk behavior of the alleged assailant.

If the alleged assailant has been confirmed to be HIV-infected, HIV-specific information about the source person, including his/her viral load, ART medication history, and history of antiretroviral drug resistance should be obtained to assist in selection of a PEP regimen [Beltrami et al. 2003]. Consultation with a provider with experience with ART is especially recommended when the source person is known to harbor drug-resistant HIV because an alternate PEP regimen may be more effective. However, initiation of the first dose of PEP should not be delayed while awaiting this information.

Recommending PEP

Initiating PEP

PEP should be initiated as soon as possible after exposure, ideally within 2 hours. (A2) Decisions regarding initiation of PEP beyond 36 hours post exposure should be made on a case-by-case basis with the realization that diminished efficacy is a consequence of delay in the timing of initiation. (A3)

The recommendation for PEP should be communicated simply and clearly to the patient, considering his/her emotional state and ability to comprehend the nature of antiretroviral treatment. (A3)

If a sexual assault victim is too distraught to engage in a discussion about PEP or make a decision about whether to initiate prophylaxis at the initial assessment, the clinician should offer a starter pack of medication and make arrangements for a follow-up appointment within 24 hours to further discuss the indications for PEP. (A3)

If a sexual assault victim decides to initiate treatment, a follow-up visit should be scheduled within 24 hours to review the decision, evaluate initial drug tolerability, reinforce the need for adherence to the regimen, and arrange for follow-up care. (A3) In New York State, hospitals providing treatment to victims of sexual assault must provide or arrange for an appointment for medical follow-up related to PEP and other care as appropriate.

Because evidence indicates the need to begin prophylaxis within hours after an exposure, the clinician is in the position of deciding how strongly to advise the victim to initiate the regimen. This requires the clinician to balance the victim’s readiness with the knowledge that the most efficacious intervention should occur promptly. If a patient is too distraught to engage in discussion, he/she should be encouraged to take a single dose of PEP, and then revisit the issue the following day. The risk of taking one dose is likely to be minimal, and the efficacy that would be lost if delayed a whole day may be salvaged. However, if the victim decides to defer making a decision at the time of the initial intervention, then the follow-up visit to consider PEP should occur within 24 hours of the exposure to ensure that PEP is started within 36 hours of exposure. If the victim is pregnant, a full discussion of the benefits and risks of prophylaxis for both maternal and fetal health should occur. Preliminary results from an ongoing observational study reported increased risk of neural tube defects in babies born to mothers were taking dolutegravir (DTG)-based antiretroviral (ARV) drug regimens at the time of conception [AIDSinfo 2018; FDA 2018]. For exposed individuals who are or could become pregnant, or who are not using effective contraception, DTG-containing regimens should be avoided until more data are available. If there are no alternatives for DTG for those of childbearing age, clinicians should strongly advise the use of effective contraception and should obtain a pregnancy test before initiating treatment (see NYSDOH AI: PEP for Non-Occupational Exposure to HIV (nPEP) Guideline > nPEP for HIV-Exposed Women Who Are Pregnant or Breastfeeding for drugs to avoid in exposed individuals who are pregnant or breastfeeding).

Payment Methods for PEP Following Sexual Assault

PEP PAYMENT METHODS

Various payment methods for PEP are available for victims of sexual assault, including Medicaid, Medicare, or the NYS Office of Victim Services (OVS). If the individual has prescription drug coverage, third-party reimbursement may cover nPEP, depending on the plan’s prescription drug policy. In cases where the medication-dispensing facility does not receive reimbursement for these services, such expenses may be included in their annual Institutional Cost Report as part of indigent care costs. Timely initiation of medication is crucial to the success of nPEP, and amendments to New York State Public Health Law, Chapter 39, Section 2805-i, effective November 27, 2012, require hospitals providing treatment to victims of sexual assault to have 7-day starter packs available on-site.

Provider reimbursement under the OVS Forensic Rape Exam Direct Reimbursement Program is intended to cover the forensic examiner’s services, including pharmaceuticals related to a sexual assault forensic examination. This reimbursement may include the cost of the initial 7-day starter pack of nPEP if the provider determines a risk of exposure. Claim forms for reimbursement under the Direct Reimbursement Program can be found in each Sexual Offense Evidence Collection Kit and can also be downloaded from the OVS website.

Documentation of a visit to a medical facility that provides a forensic physical examination satisfies the OVS reporting requirement, thereby providing victims who are either unwilling or unable to report the crime to the police the opportunity to file a regular compensation claim. Victims of sexual assault may also contact a Rape Crisis Center or Victim Advocate Program in their county or region for assistance in filing regular compensation claims with OVS, particularly when an emergency award is needed from the OVS (see below). Many of these agencies have 24-hour hotlines. For more information and for a list of Victim Advocate Programs and other resources, consult the OVS website.

The OVS has an “emergency award” procedure in addition to its normal compensation process to ensure continued availability of PEP for sexual assault victims beyond the initial 7-day starter pack supply. The process for requesting an emergency award is as follows:

Claimant files a regular claim application with the OVS, indicating that medication for HIV post-exposure prophylaxis is necessary and requests an emergency award

OVS makes an expedited determination for the purposes of the emergency award

If the OVS determines it can grant an emergency award, then OVS directly reimburses pharmacy providers on behalf of the claimant.

HIV Testing

HIV Testing of the HIV-Exposed Victim

Clinicians should perform baseline rapid HIV testing of the victim. PEP should be initiated without waiting for the results of the HIV test. (A3)

Refusal to undergo baseline testing should not preclude initiation of PEP. (A3)

Baseline HIV testing of the victim identifies individuals who were already infected with HIV at the time of presentation. This allows decisions to be made regarding the initiation of ART to treat established HIV infection rather than PEP to prevent it (see NYSDOH AI: When to Initiate ART Guideline). However, the PEP regimen should not be discontinued until the positive result is repeated with a supplementary assay.

If the victim prefers not to undergo HIV testing in the emergency department setting, a referral should be arranged to obtain HIV testing the next day. If excess blood is remaining from blood specimens obtained in the emergency department for other reasons, it may be used for HIV testing later, but only if informed consent has been obtained. A potential consequence of initiating PEP without baseline HIV testing in the context of sexual assault is the inability to subsequently establish that the assault resulted in HIV transmission, should the victim later test positive for HIV.

The emergency department provider should obtain the HIV test; however, with agreement of all parties, this responsibility may be transferred to the treating provider or primary care provider. If the victim is being treated with PEP, this responsibility should be coordinated with the treating provider, who may need to discuss long-term treatment options with the victim should he/she seroconvert. If the victim is not under the care of a primary care clinician, the emergency department provider who has obtained the test is responsible for ensuring that the result is promptly communicated to the victim.

KEY POINT

A negative baseline HIV test only demonstrates that the victim was not previously infected with HIV before the exposure occurred; the baseline HIV test cannot determine whether the victim was infected as a result of the assault for which he/she is presenting.

STIs Other Than HIV and Emergency Contraception

PEP for STIs Other Than HIV

For sexual assault victims, clinicians should offer prophylactic medication to prevent gonococcal and chlamydial infections. Routine baseline testing for STIs is not recommended in cases of sexual assault. (A3)

Pregnancy Testing

Clinicians should obtain baseline pregnancy testing for sexual assault victims who are of childbearing age. (A2)

Emergency Contraception

Emergency contraception should be discussed and offered to individuals who could become pregnant as a result of the assault. (A2)

In cases of sexual assault, all patients are offered prophylactic medication to prevent gonorrhea and chlamydia infection given the high rates of infection after assault [Reynolds et al. 2000]. Trichomoniasis and bacterial vaginosis can be diagnosed or excluded in the emergency department if microscopy is available; otherwise empiric treatment should be administered. Routine testing for gonorrhea, chlamydia, and syphilis is not recommended at the initial exam in the setting of sexual assault because results of that testing would determine whether the patient had an STI prior to the assault. This information can be used to bias a jury against a victim in court [NYSDOH 2008].

Emergency Contraception

Emergency contraception for patients who could become pregnant should be initiated within 72 hours of the exposure to be effective; optimally, pregnancy prophylaxis should be initiated within 12 hours of the exposure. The following websites offer more information about the use of emergency contraception:

Role of the Rape Crisis Advocate and Sexual Assault Examiner

Planning for Follow-Up

The plan for follow-up care should be discussed with the rape crisis advocate or an outreach worker who will be working with the victim following the victim’s departure from the emergency department or equivalent healthcare setting. (A3)

New York State Public Health Law 2805-i requires that hospitals providing treatment to victims of sexual assault advise the victim of the availability of services provided by the local rape crisis or victim assistance organization and secure such services as requested by the patient. The primary role of the rape crisis advocate is to provide the victim with emotional support, advocacy, information, counseling, and accompaniment services, and to facilitate informed decision-making at a time when the victim may be in crisis. Advocates do not provide health care or collect evidence; they can, however, enhance the efforts of healthcare staff through the provision of information regarding medical and legal options.

The initial response a victim of rape or sexual assault receives when seeking health care or reporting the crime has a profound influence on that individual’s subsequent recovery. The use of healthcare practitioners known as Sexual Assault Forensic Examiners (SAFE) has helped improve the care that victims receive. The NYSDOH certifies all appropriately qualified individuals as SAFEs. A SAFE is a specially trained registered nurse, nurse practitioner, physician, or physician’s assistant.

Public Health Law requires that all SAFE Centers of Excellence have a SAFE either available on-site or on-call within 60 minutes of the victim’s arriving at the hospital, except under exigent circumstances [New York State Public Health Law 2001]. In New York State, the standard of care for rape and sexual assault victims presenting at healthcare settings is comprised of comprehensive and high-quality medical care, collection of forensic evidence, and respectful and sensitive treatment. The NYSDOH recommends the use of SAFEs in all hospitals to assist in meeting this standard. The SAFE should be an active participant in the discussion regarding the initiation of HIV PEP. SAFEs help to ensure the best medical, legal, and psychological outcomes for the adult victim of sexual assault and provide compassionate emotional support. They are trained to provide care to victims of sexual assault and to collect and preserve forensic evidence to support prosecution, if the victim decides to report the crime to law enforcement.

The treating clinician, preferably a SAFE, should coordinate care to encourage medical follow-up and adherence to PEP. The rape crisis advocate may become the crucial link between the victim and the provider, clarifying communication and facilitating follow-up care for the victim. When the victim does not have a primary care provider or has difficulty arranging access to a clinician experienced in HIV PEP, this link becomes especially important. Support from the advocate will increase the likelihood that the individual will adhere to the PEP regimen and that the primary care provider, PEP prescriber, or SAFE will be notified of medical problems. The advocate can also ensure that problems are addressed expeditiously as they arise.

The Rape Crisis and Sexual Violence Prevention Program is the only New York State agency-sponsored program that focuses on sexual assault prevention and treatment for survivors of sexual assault. Located within the Bureau of Women’s Health, the Rape Crisis and Sexual Violence Program’s mission is to support activities to prevent sexual assault and to ensure that services are available, accessible, and appropriate for sexual assault survivors.

The Rape Crisis and Sexual Violence Prevention Program is committed to improving New York State’s response to sexual assault survivors through advocacy, policy development, and coordination and oversight of a statewide network of rape crisis service providers. Technical assistance on sexual assault issues is provided within the NYSDOH, with other State agencies, healthcare facilities, and professional organizations.

Reference

Appendix: Sexual Assault Forensic Examiner (SAFE) Program

October 2014

The Sexual Assault Forensic Examiner (SAFE) program is a collaborative effort in which hospitals work with emergency department staff, Rape Crisis and Sexual Violence Prevention Programs, law enforcement, prosecutors’ offices, and other agencies that provide services to victims of sexual assault to provide a team approach to meet and improve the needs of the sexual assault victim.

The goals of the SAFE program are to:

Provide timely, compassionate, patient-centered care in a private setting that provides emotional support and reduces further trauma to the patient

Ensure the quality of collection, documentation, preservation, and custody of physical evidence by utilizing a trained, New York State Department of Health-certified sexual assault forensic examiner to perform the exam

Utilize an interdisciplinary approach by working with rape crisis centers and other service providers, law enforcement, and prosecutors’ offices to effectively meet the needs of the sexual assault victim and the community

Provide expert testimony when needed if the patient chooses to report the crime to law enforcement

All Recommendations

On May 18, 2018, the FDA and the DHHS Antiretroviral Guidelines Panels issued statements in response to preliminary results from a study that reported increased risk of neural tube defects in babies born to mothers taking DTG-based ARV drug regimens at the time of conception [AIDSinfo 2018; FDA 2018].

Until more data become available, DTG-containing regimens should be avoided in any HIV-exposed individual who is or could become pregnant and is not using effective contraception. If there are no alternatives to DTG for individuals of child-bearing potential, then clinicians should strongly advise the use of effective contraception and should obtain a pregnancy test before initiating treatment.

Introduction

Victims of sexual assault should be treated in an emergency department or equivalent healthcare setting where all appropriate medical resources are available as needed. (A3)

Assessment

When deciding whether to recommend the initiation of PEP following sexual assault, the clinician should assess and carefully weigh the following factors: (A3)

Whether or not a significant exposure has occurred during the assault

Knowledge of the HIV status of the alleged assailant

Whether the victim is ready and willing to complete the PEP regimen

The clinician’s decision to recommend PEP should not be influenced by the geographic location of the assault. (A2)

Degree of Risk Based on Type of Exposure

Clinicians should recommend HIV PEP to victims when significant exposure may have occurred, as defined by direct contact of the vagina, penis, anus, or mouth with the semen, vaginal fluids, or blood of the alleged assailant, with or without physical injury, tissue damage, or presence of blood at the site of the assault. (A2)

PEP should also be offered in cases when broken skin or mucous membranes of the victim have been in contact with blood, semen, or vaginal fluids from the alleged assailant. Similarly, PEP should be offered in cases of bites that result in visible blood. (A2)

Considering the HIV Status of the Alleged Assailant

Unless the identity and HIV status of the alleged assailant have been clearly established to assist with the decision-making, PEP should be promptly initiated and should not be delayed while awaiting test results from the alleged assailant. (A2)

Even when the alleged assailant is known to be HIV-infected, the decision to recommend PEP should be based on the nature of the exposure and the victim’s ability to complete the regimen. (A3)

If PEP has been initiated and HIV screening tests from the alleged assailant are found to be negative, including rapid test and 3rd- or 4th-generation EIA or HIV RNA assay,* then PEP should be discontinued. Decisions to discontinue PEP should be made in consultation with a clinician experienced in HIV PEP. (B3)

*Testing protocols for alleged assailants are dependent on whether the test results will affect the victim’s completion of PEP (seeDefendant Testing Guidance).

Initiating PEP

PEP should be initiated as soon as possible after exposure, ideally within 2 hours. (A2) Decisions regarding initiation of PEP beyond 36 hours post exposure should be made on a case-by-case basis with the realization that diminished efficacy is a consequence of delay in the timing of initiation. (A3)

The recommendation for PEP should be communicated simply and clearly to the patient, considering his/her emotional state and ability to comprehend the nature of antiretroviral treatment. (A3)

If a sexual assault victim is too distraught to engage in a discussion about PEP or make a decision about whether to initiate prophylaxis at the initial assessment, the clinician should offer a starter pack of medication and make arrangements for a follow-up appointment within 24 hours to further discuss the indications for PEP. (A3)

If a sexual assault victim decides to initiate treatment, a follow-up visit should be scheduled within 24 hours to review the decision, evaluate initial drug tolerability, reinforce the need for adherence to the regimen, and arrange for follow-up care. (A3) In New York State, hospitals providing treatment to victims of sexual assault must provide or arrange for an appointment for medical follow-up related to PEP and other care as appropriate.

Discussions regarding initiation of PEP should include the following: (A3)

Potential benefit, unproven efficacy, and potential toxicity of PEP

Duration of PEP regimen

Importance of adherence to the treatment regimen to prevent PEP failure or the development of drug resistance should infection occur

Need to reduce risk and prevent exposure to others

Clinical and laboratory monitoring and follow-up schedule

Signs and symptoms of acute HIV infection

HIV Testing of the HIV-Exposed Victim

Clinicians should perform baseline rapid HIV testing of the victim. PEP should be initiated without waiting for the results of the HIV test. (A3)

Refusal to undergo baseline testing should not preclude initiation of PEP. (A3)

PEP for STIs Other Than HIV

For sexual assault victims, clinicians should offer prophylactic medication to prevent gonococcal and chlamydial infections. Routine baseline testing for STIs is not recommended in cases of sexual assault. (A3)

Pregnancy Testing

Clinicians should obtain baseline pregnancy testing for sexual assault victims who are of childbearing age. (A2)

Emergency Contraception

Emergency contraception should be discussed and offered to individuals who could become pregnant as a result of the assault. (A2)

Planning for Follow-Up

The plan for follow-up care should be discussed with the rape crisis advocate or an outreach worker who will be working with the victim following the victim’s departure from the emergency department or equivalent healthcare setting. (A3)

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